Hormone-replacement trial arouses concern. The Women's
Health Initiative (WHI) has stopped part of a large study designed
to assess the benefits and risks of hormone replacement therapy
(HRT) with a combination of estrogen and progesterone. The arm
of the study that was stopped included more than 16,000 women
aged 50-79 years whose uterus was intact when the study began.
The researchers examined the balance of risks and benefits related
to coronary heart disease, breast cancer, stroke, pulmonary embolism,
endometrial cancer, colorectal cancer, hip fracture, and death
due to other causes.

After an average of 5.2 years of follow-up, the data showed
increases in the risk of breast cancer, heart disease, and stroke,
but decreased risk of colon and rectal cancer, uterine cancer,
hip fracture, and death from other causes. However, there was
no change in the the overall risk of cancer, dying from breast
cancer, or dying from any other cause; and comparable increased
risks were not seen in an estrogen-only portion of the WHI study,
which is still ongoing. The researchers concluded that combined
estrogen-progestin HRT (a) should not be used on a population-wide
basis for postmenopausal women and (b) should not be started or
continued for the purpose of preventing coronary heart disease
in apparently healthy women. They also concluded that the risks
should be considered when choosing among the drugs available to
prevent osteoporosis. [Writing Group for the Women's Health Initiative
Investigators. Risks
and benefits of estrogen plus progestin in healthy postmenopausal
women: Principal results from the Women's Health Initiative Randomized
Controlled Trial. JAMA 288:321-333, 2002] An accompanying
editorial concluded:

Although the WHI trial results are reported primarily in
terms of relative risk, the absolute risk of harm to an individual
woman is very small: Among 10,000 women taking the drug for a
year, there will be 7 more coronary heart disease events, 8 more
invasive breast cancers, 8 more strokes, and 8 more pulmonary
emboli, but 6 fewer colorectal cancers and 5 fewer hip fractures.
When counting all events over the 5.2 years of the trial, the
excess number of events in the active drug group was 100 per
10 000 (or 1 in 100 women). This is still a small risk, but it
demonstrates that risks from the drug add up over time.

The purpose of healthy women taking long-term estrogen/progestin
therapy is to preserve health and prevent disease. This study
provides strong evidence that the opposite is happening for important
aspects of women's health, even if the absolute risk is low.
Given these results, clinicians should stop prescribing this
combination (1 daily tablet containing 0.625 mg of conjugated
equine estrogen plus 2.5 mg of medroxyprogesterone acetate) for
long-term use. Other regimens may have different results, but
the 3 studies reported to date in the United States with other
regimens have all found an increased risk of breast cancer.

This study and many others show that HRT protects against
osteoporosis. There are alternative preventive strategies, at
least one of which also lowers the risk of breast cancer, although
cardiovascular its effects are not clear.

The WHI trial does not specifically address whether short-term
HRT should be used for managing menopausal symptoms, but it suggests
that short-term use has risks for cardiovascular disease. The
possibility of these small absolute risks should be balanced
against the severity of symptoms and benefit of treatment. [Fletcher
SW, Colditz GA. Failure
of estrogen plus progestin therapy for prevention. JAMA 288:366-368,
2002]

What should women do? Most important, they should realize that
the goal of good medical care is to live as long and healthfully
as possible and not just to avoid a particular disease. Although
this WHI report raises legitimate concerns, it does not show excess
deaths among users of the combined HRT treatment. Since cardiovascular
disease is the leading cause of death, it is important that cardiovascular
risk factors be assessed and managed. With respect to HRT, women
should review their individual circumstances with a knowledgeable
physician to determine whether HRT makes sense for them ias part
of an overall strategy to optimize their health and reduce the
risk of health problems and premature death.

"Male menopause" advocate
barred from Internet prescribing. Malcolm Carruthers, a London
physician who prescribed male hormones over the Internet has been
censured by the British General Medical Council (GMC) for serious
professional misconduct. Carruthers'
Web site included a questionnaire with which men could test
themselves for possible "male menopause" ("andropause").
If their score was 10 or more, the site recommended "AndroScreen"
testing, which cost from £70 (about US$100) to £575.00
($800), depending on what was included. The test was constructed
so that many people with normal hormone levels would be advised
to undergo unnecessary hormone testing. The misconduct involved
(a) diagnosing and recommending high-dose testosterone injections
for male menopause in a 70 year old patient with Alzheimer's disease
without ever seeing him or his records and (b) improperly criticizing
the patient's local physician who believed that the prescribed
dose was too high. [Dyer O. Exponent
of "male menopause" censured by GMC. British Medical
Journal 325:65, 2002] Carruthers, who authored The Testosterone
Revolution, chairs the Andropause
Society, a group campaigning for wider recognition of a "male
menopause." The prevailing scientific viewpoint is that Carruthers'
concept is not valid. [Jacobs HS. The
male menopause—does it exist? (negative view). British
Medical Journal 320:858-861, 2000]

Study finds no link between cardiovascular death rates and
vitamin use. The Physicians Health Study has found that taking
vitamin E, vitamin C, or multivitamins was not associated with
a significant decrease in death rates from cardiovascular disease.
The study included 83,639 male physicians in the United States
who had no history of heart disease at baseline and were followed
for an average of 5.5 years. [Muntwyler J and others. Vitamin
supplement use in a low-risk population of US male physicians
and subsequent cardiovascular mortality Archives of Internal
Medicine 162:1472-1476, 2002]

Diet pills containing fenfluramine cause liver failure.
The governments of China and Singapore have outlawed the marketing
of diet pills found to contain fenfluramine as an undeclared ingredient.
The pills, marketed as Slim 10 in Singapore, and "First Generation
Yuzhitang Diet Capsules in China, have been linked to several
deaths and more than 30 other cases of serious illness in China,
Singapore, and Japan. Fenfluramine
was banned in the United States in 1997.

French antismoking ad draws huge response. The Associated
Press has reported that half a million people telephoned a toll-free
number in response to a television ad which stated that a commonly
consumed product had been found to contain traces of cyanuric
acid, mercury, acetone. and ammonia. The product, which the ad
did not identify, was the cigarette. The National Health Institute
for Prevention and Education, which sponsored the ad, said it
was intended to wake people up to the dangers of cigarette smoking.

Rise in cigarette tax evasion predicted. Knowledgeable
observers have predicted that the recent rise in cigarette taxes
(17 states have acted this year) will lead to more aggressive
smuggling and bolder use of the Internet as a tax-evading tobacco
shop. Smuggling is encouraged by the low taxes in the tobacco-producing
states of Virginia (2.5¢ per pack), Kentucky (3¢), North
Carolina (5¢), and South Carolina (7¢). The Bureau of
Alcohol, Tobacco and Firearms Control has said that large-scare
organized crime gangs as well as isolated individuals are involved
in smuggling operations. In addition, the number of Internet cigarette
outlets has increased considerably during the past two years;
and some American Indians claim that their Internet sales should
be tax-free. [Crary D. Cigarette taxes might fuel smuggling, tax
evasion. Associated Press, July 14, 2002] In December 2001, Rep.
Martin Meehan (D-MA) introduced the Tobacco Free Internet for
Kids Act, which would ban Internet tobacco sales to minors,
require Internet tobacco vendors to verify the purchaser's identity
and age, and use shipping methods that require purchasers to sign
for delivery and show photo identification.